510(k) Report

510(k) · Cleared

Cleared

29-140 to 29-196 Various Bone Chisels (Osteotomes,

K851788510(k) TraditionalCleared Jun 20, 198556-day reviewClass I21 CFR 878.4800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Artiberia · FZO Chisel, Surgical, Manual

Cleared on Jun 20, 1985 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 20, 1985
Review
56 days
Class
Class I
Product code
FZO
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K851788Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All FZO devices

FZO Chisel, Surgical, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZO

FDA has decided no FZO device since 2007.

Median 510(k) review, days · FZO

Too few FZO 510(k)s in any year since 2007 to give a median.

Recalls per year · FZO

No recall names FZO since 2007.

Adverse event reports per year · FZO

25in 2025

2008: 22010: 22011: 22012: 22013: 332014: 52015: 142016: 102017: 152018: 662019: 252020: 172021: 282022: 182023: 212024: 192025: 25
2007high 66 (2018) · low 0 (2007)2025

MAUDE reports naming product code FZO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—02
20090—00
20100—02
20110—02
20120—02
20130—033
20140—05
20150—014
20160—010
20170—015
20180—066
20190—025
20200—017
20210—028
20220—018
20230—021
20240—019
20250—025
20260—0—

More from Artiberia

79 FDA decisions under this applicant name. See the company

  • K8517451-100 Universal Set Otoscope & Larynx Exploraton BArtiberia · 1985
  • K85178627-230 to 27-234 Various Cast Breakers, WolfArtiberia · 1985
  • K8517272020-1/2 to 2220 Various Dental Wax & Modelling CAArtiberia · 1985
  • K8517191070/15 to 1078/17 Various Types Needle HoldersArtiberia · 1985
  • K851718930/0 to 950/6 Various Types of Bone CurettesArtiberia · 1985

Recent decisions in FZO

The FZO category page

  • K834198Jakobi Surg. Instruments #12 40/41Imm Enterprises, Ltd. · 1984

https://510kreport.com/device/K851788 · printed Nov 4, 2026

Cite this page

510(k) Report. “K851788: 29-140 to 29-196 Various Bone Chisels (Osteotomes,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K851788

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026